International Study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE)

NCT ID: NCT02793141

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1657 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2021-02-23

Brief Summary

The International study on NoSocomial Pneumonia in Intensive CaRE (PneumoINSPIRE) is a prospective, international, multicentre, observational, cohort study. The study aims to provide up-to-date and generalisable information on current worldwide epidemiology and clinical practice associated with diagnosis and management of nosocomial pneumonia in Intensive Care Unit (ICU) patients.

PneumoINSPIRE study is endorsed by the European Society of Intensive Care Medicine (ESICM).

Detailed Description

Specifically, the study aims to:

• Evaluate the global epidemiology of nosocomial pneumonia in ICU patients, analysing responsible pathogens and resistance pattern by type of pneumonia and geographical region.
• Describe on a global scale current clinical practice regarding diagnosis and determine the degree of concordance between the diagnosis of nosocomial pneumonia in routine clinical practice and the official definitions including: a) ATS/IDSA 2005 guidelines; b) CDC/NHSN Surveillance Definitions (version January 2015, modified April 2015).
• Identify on a global scale variable treatment decisions with emphasis on therapeutic schemas, appropriateness, de-escalation decisions and their relation to outcomes.

Secondary objectives include:

• Evaluate nosocomial pneumonia in specific subgroups of critically ill patients (such as, chronic obstructive pulmonary disease [COPD], the elderly, postoperative, trauma patients).
• Describe the differences between nosocomial pneumonia in non-intubated ICU patients and VAP.
• Compare the characteristics and outcomes between patients with nosocomial pneumonia in ward patients later transferred to the ICU and non-intubated ICU patients with nosocomial pneumonia.

This international study will explore clinical details for nosocomial pneumonia in the ICU setting: practice variations among countries and continents, diagnostic and treatment modalities, implicated pathogens and their resistance patterns, resolution patterns and risk factors for unfavourable outcomes. In view of these, this global multicentre study shall provide useful information for the elaboration of future recommendations on diagnostic and treatment approaches for nosocomial pneumonia in the ICU.

Inclusion criteria:

ICU patients with a diagnosis of nosocomial pneumonia, including:

• Admission to the ICU with diagnosis of HAP that developed in the ward in non-intubated patients (Ward HAP)
• The first episode of ICU-acquired pneumonia that developed in non-intubated patients (ICU-HAP)
• The first episode of ICU-acquired pneumonia that developed in patients receiving invasive ventilation(i.e. Ventilator-Associated Pneumonia (VAP)).

Exclusion criteria:

• Age < 18 years
• Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility (i.e. the time of clinical diagnosis)
• Previous inclusion in the study

Research sites:

More than 150 ICUs from 25 or more countries worldwide that will agree to participate in the study.

Sample size:

A minimum of 10 consecutive ICU patients with nosocomial pneumonia as described above will be recruited per site. A sample size of at least 1000 ICU patients with nosocomial pneumonia is anticipated to comprise the dataset. This sample size has been chosen to provide generalisable data for each geographic region and to satisfy power considerations.

Statistical analysis:

Descriptive analytic, techniques and parametric and non-parametric tests will be used to explore diagnostic, microbiological or subgroup differences as well as clinical outcomes of nosocomial pneumonia. Cox regression will be used to predict dichotomous outcomes of interest, including mortality and pneumonia resolution. Independent predictors and associated hazard ratios with 95% confidence intervals will be reported. A two-sided p-value less than 0.05 will be considered statistically significant.

Proposed Start and End Date:

The first site is anticipated to commence recruitment in March 2016 with staggered site recruitment; however, sites are anticipated to start recruitment during the first half of 2016; each site will commence recruitment as soon as relevant Institutional Review Board approvals have been obtained. Recruitment will continue until the minimum target of 10 patients has been reached. Sites will have the opportunity for further recruitment while the study is active. Completion of recruitment is anticipated to occur by end December 2018.

Dissemination of Findings:

Summary data will be presented in a timely manner at national and international conferences and in peer-reviewed journals.

Conditions

Nosocomial Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICU Nosocomial Pneumonia

Nosocomial pneumonia (hospital-acquired pneumonia) with onset in non-intubated ward patients (= or \> 48 hours after hospital admission) that due to deterioration are subsequently admitted to ICU or nosocomial pneumonia (hospital-acquired pneumonia) with onset in non-intubated ICU patients (= or \>48 hours after hospital admission) or ventilator-associated pneumonia with onset = or \> 48 hours after intubation. No intervention will be administered.

No intervention

Intervention Type: OTHER

No intervention will be administered

Interventions

No intervention

No intervention will be administered

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

ICU patients with a diagnosis of nosocomial pneumonia, including:

• Admission to the ICU with diagnosis of HAP that developed in the ward in non-intubated patients (Ward HAP)
• The first episode of ICU-acquired pneumonia that developed in non-intubated patients
• The first episode of ICU-acquired pneumonia that developed in patients receiving invasive ventilation (i.e. Ventilator-Associated Pneumonia (VAP)).

Exclusion Criteria

• Age < 18 years
• Patients with nosocomial pneumonia receiving palliative treatment at the time of assessment for eligibility
• Previous inclusion in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society of Intensive Care Medicine

OTHER

Sponsor Role: collaborator

The University of Queensland

OTHER

Sponsor Role: lead

Responsible Party

Despoina Koulenti, MD, PhD

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Despoina Koulenti, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Post-doctoral Research Fellow, Burns Trauma and Critical Care Research Centre, Faculty of Medicine, The University of Queensland

Jeffrey Lipman, MBBCh, MD

Role: STUDY_DIRECTOR

Director of Burns Trauma and Critical Care Research Centre, School of Medicine, The University of Queensland

Locations

Royal Brisbane and Womens Hospital (RBWH)

Brisbane, , Australia

University Critical Care Department, Aghioi Anargyroi Hospital

Athens, Attica, Greece

Countries

Australia; Greece

References

Koulenti D, Armaganidis A, Arvaniti K, Blot S, Brun-Buisson C, Deja M, De Waele J, Du B, Dulhunty JM, Garcia-Diaz J, Judd M, Paterson DL, Putensen C, Reina R, Rello J, Restrepo MI, Roberts JA, Sjovall F, Timsit JF, Tsiodras S, Zahar JR, Zhang Y, Lipman J; Working Group on Pneumonia of the European Society of Intensive Care Medicine. Protocol for an international, multicentre, prospective, observational study of nosocomial pneumonia in intensive care units: the PneumoINSPIRE study. Crit Care Resusc. 2023 Oct 18;23(1):59-66. doi: 10.51893/2021.1.OA5. eCollection 2021 Mar.

Reference Type: DERIVED

PMID: 38046390 (View on PubMed)

Other Identifiers

2015000302

Identifier Type: -

Identifier Source: org_study_id